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Biotechnology major Biocon on Wednesday said a US court has invalidated a Sanofi patent on the insulin glargine device, thus removing a legal hurdle to commercialising Semglee co-developed with Mylan, in the US market.
The US District Court of New Jersey found the device patent claims asserted by Sanofi against Biocon and Mylan’s insulin glargine product ‘not infringed’ and ‘invalid’ for lack of written description, Biocon said in a filing to the BSE.
As previously announced, Sanofi’s formulation patents were earlier affirmed to be invalid by the Federal Circuit, it added.
The new drug application (NDA) for Semglee is under active review by the US Food and Drug Administration (USFDA), Biocon said.
The US health regulator has set a target action date for the insulin glargine application in June 2020. The market opportunity for insulin glargine in the US is estimated at $2.2 billion, it added.
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